Radial Shock Waves for Functional Disability in Stroke

Marta Imamura

Status: Completed

Conditions: Ischemic Stroke

Treatments: Device: Sham Radial Shockwave; Device: Active Radial Shockwave

Study type: Interventional

Funder types: Other

Identifiers

NCT02924168

19109813.1.0000.0068

Details and patient eligibility

About

This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery;
• 6 to 24 months after stroke date;
• Stability observed in clinical medical evaluation
• Granting of written informed consent to participate in the study

Exclusion criteria

• Individuals with a score lower than 24 on the Mini-mental test;
• Previously documented strokes
• Pregnancy
• Patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study
• Bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy
• Psycho-affective disorder that prevents adherence
• Joint pain that occurs within the movement range of therapies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Active Radial Shockwave

Experimental group

Description:

Every patient will receive 5,000 continuous pulses per treatment session, at 3.5 to 4 bar air pressure (resulting in an energy flux density \[EFD\] of approximately 0.07 mJ/mm2) and at 15Hz frequency. A total of 4 sessions will be performed.

Treatment:

Device: Active Radial Shockwave

Sham Radial Shockwave

Sham Comparator group

Description:

Every patient will receive 5,000 continuous pulses per treatment session, without air pressure (resulting in no EFD) and at 15Hz frequency. A total of 4 sessions will be performed.

Treatment:

Device: Sham Radial Shockwave